onstipation, diarrhea, fatigue, pyrexia, weakness, lower limb edema, anorexia, decreased weight, bone pain, myalgia, arthralgia, back pain, malignant neoplasm aggravated, headache, dizziness, insomnia, paresthesia, dyspnea, cough, and abdominal pain.
There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including zoledronic acid. Before being given zoledronic acid, patients should tell their doctor if they are aspirin-sensitive.
Manufactured by
Novartis Pharma Stein AG
Stein, Switzerland for
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
© Novartis
T2011-90
PRINCIPAL DISPLAY PANEL
Package Label – 4 mg / 5 mL
Rx OnlyNDC 0078-0387-25
Zometa® (zoledronic acid) Injection
4 mg / 5 mL
Concentrate for Intravenous Infusion
1 vial
Sterile Concentrate
Not for direct injection. Dose must be diluted.
See package insert for Preparation of Solution.
Do not mix with calcium-containing infusion solutions.
PRINCIPAL DISPLAY PANEL
Package Label – 4 mg / 100 mL
Rx OnlyNDC 0078-0590-61
Zometa®
(zoledronic acid) Injection
Sterile Solution
4 mg / 100 mL
Solution for Intravenous Infusion
Single use only. Discard unused portion.
For more information visit
www.us.zometa.com
or call
1-866-4-Zometa
(1-866-496-6382)
ZOMETA
zoledronic acid injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0387
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLEDRONIC ACID (ZOLEDRONIC ACID) ZOLEDRONIC ACID 4mg in5mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 220mg in5mL
SODIUM CITRATE 24mg in5mL
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0387-25 1 VIAL (1 VIAL) in 1 CARTON contains a VIAL
1 5 mL in 1 VIAL This package is contained within the CARTON(0078-0387-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021223 08/20/2001
ZOMETA
zoledronic acid injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0590
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZOLEDRONIC ACID (ZOLEDRONIC ACID) ZOLEDRONIC ACID 4mg in100mL
Inactive Ingredients
Ingredient Name Strength
MANNITOL 5100mg in100mL
SODIUM CITRATE 24mg in100mL
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0590-61 1 BOTTLE (1 BOTTLE) in 1 CARTON contains a BOTTLE
1 100 mL in 1 BOTTLE This packa
